财中社12月16日电翰森制药(03692)发布公告,宣布其B7-H3靶向抗体药物偶联物HS-20093获得欧洲药品管理局(EMA)优先药物(PRIME)认定。该药物由公司与GlaxoSmithKline Intellectual Property (No.4) Limited(GSK)签署的许可协议下开发,GSK获得了全球独占许可(不包括中国内地、香港、澳门及台湾),用于开发、生产及商业化HS-20093。
HS-20093是一种新型的B7-H3靶向抗体药物偶联物,正在进行多项I期、II期及III期临床研究,适应症包括肺癌、肉瘤、头颈癌及其他实体瘤。此外,GSK已于2024年8月20日获得美国食品药品监督管理局(FDA)对GSK227的突破性疗法认定,用于治疗复发或难治性的广泛期小细胞肺癌(ES-SCLC)患者,并于2024年11月1日被中国国家药品监督管理局纳入突破性治疗药物。
(文章来源:财中社)
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